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Completed

NCT Number: NCT05104554

School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and school performance/attendance among in-school adolescents in Zanzibar, Tanzania.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zanzibar Association for People Living with HIV/AIDS

Welezo, Zanzibar, Tanzania

About this study

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Zanzibar. Findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in Zanzibar.

This will be a cluster randomized study with 3 arms. At the beginning of the academic year, 42 schools will be enrolled (14 schools per arm) to receive either 1) supplementation with weekly iron and folic acid (IFA); 2) supplementation with daily multiple micronutrient supplements (MMS) (including iron and folic acid as components); or 3) to serve as controls. Students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene [WASH]). The program will be evaluated at the end of year 1, comparing effects of weekly IFA and daily MMS on anemia status and school attendance/performance. The more effective strategy (MMS or IFA) will be scaled up to all the study schools for year 2 of the intervention, and the outcomes will be re-assessed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescents aged 10-17 years
  • Enrolled in secondary school form 1 at study initiation
  • Member of one of the selected classes in a participating school
  • Consent provided by the parent
  • Assent provided by the adolescent
  • Fluency in Swahili and/or English

Exclusion criteria

  • No informed consent from parent or assent from adolescent
  • Self-reported pregnancy

Treatment and study plan

Iron and Folic Acid (IFA)

Dietary Supplement

IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)

Multiple Micronutrient Supplement (MMS)

Dietary Supplement

MMS: Daily regimen of one multiple micronutrient tablet containing fifteen micronutrients in the United Nations International Multiple Micronutrient Preparation (UNIMMAP) preparation. Composition includes vitamin A (800 ug), vitamin D (5 ug), vitamin E (10 mg), vitamin C (70 mg), vitamin B1 (1.4 mg), vitamin B2 (1.4 mg), niacin (18 mg), vitamin B6 (1.9 mg), vitamin B12 (2.6 ug), folic acid (400 ug), iron (30 mg), zinc (15 mg), copper (2 mg), selenium (65 ug), and iodine (150 ug).

Primary outcomes

  1. Anemia status

    Time frame: Up to one year

    Anemia will be defined based on the sex- and age- specific WHO cutoffs:

    • Children 12-14 years: < 120 g/L
    • Non-pregnant women ≥ 15 years: < 120 g/L
    • Pregnant women: < 110 g/L
    • Men ≥ 15 years: < 130 g/L

Secondary outcomes

  1. School attendance

    Time frame: Up to one year

    Number of days of missed school per student

  2. School retention

    Time frame: Up to one year

    Number of students who drop out of school

  3. School performance

    Time frame: Up to one year

    Percent of students who pass to the next grade at the end of the year

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Africa Academy for Public Health
  • Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)

Registry information

Acronym: SAMIA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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